Lubricant compositions, condom products and methods of making same

ABSTRACT

Warming personal lubricant compositions, condom products including such compositions and methods of making such condom products are disclosed. The present warming lubricant compositions include at least about 50% by weight of a polyalkylene glycol component, preferably including at least two portions of different molecular weights, and an effective amount of a viscosity inducing component.

RELATED APPLICATION

This application is a continuation-in-part of U.S. patent applicationSer. No. 11/089,953, now U.S. Pat. No. 7,405,186, filed Mar. 25, 2005,the disclosure of which is hereby incorporated in its entirety byreference.

BACKGROUND OF THE INVENTION

The present invention relates to lubricant compositions, condom productsincluding lubricant compositions and methods of making condom products.More particularly, the invention relates to warming lubricantcompositions, for example, personal lubricant compositions, condomproducts including condoms lubricated with warming lubricantcompositions, and method of making such condom products.

Personal lubricants, for example, in the form of pourable liquids,pourable low viscosity thixotropic gels, jellies and the like, are knownand are useful for providing lubricity to various parts of the humanbody, for example, to mucous membranes, such as the oral, rectal,vaginal and the like mucosa. For example, see Ahmad et al U.S. Pat. No.5,885,591, the disclosure of which is incorporated in its entiretyherein by reference. Certain such lubricants have been proposed whichgenerate heat or warming when placed in contact with the human body.

Using condoms lubricated with warming lubricants has also been proposed.Producing such lubricated condoms is somewhat challenging, particularlyif the lubricant is to be applied both inside and on the outside of thecondom. Conventional machinery used in condom manufacture mandates thatthe lubricant composition has relatively tight specifications, forexample, in terms of viscosity, tackiness and stringiness, as well asproviding the desired degree of lubricity and warming or heatgeneration.

There continues to be a need for new warming lubricant compositions,condom products including warming lubricants and methods of making suchcondom products.

SUMMARY OF THE INVENTION

New lubricant compositions, condom products and methods of making condomproducts have been discovered. The present lubricant compositions havechemical make-ups which provide for enhanced/increased heat generationor warming, for example, relative to one or more prior art lubricants.In addition, the present compositions can have relatively widely varyingchemical make-ups, and therefore, can be employed in many applications,for example, as stand alone lubricant products, for example, personallubricant products, in combination with one or more medications, such asanti-fungal agents and the like, and/or in combination with devices,such as condoms and the like. In one embodiment, the present lubricantcompositions are particularly useful to provide lubrication for condoms,for example, in packaged condom products.

In general, the present lubricant compositions are relativelystraightforward in make-up and manufacture. The compositionalflexibility of the present lubricants is one important aspect inproviding useful methods of making condom products. Such compositionsare effective and enjoyable in use, whether as a stand-alone product orin combination with one or more medications and/or devices.

In one broad aspect, the present lubricant compositions comprise apolyalkylene glycol component present in an amount of at least about 50%by weight of the composition; and an effective amount of a viscosityinducing component, preferably other than a cellulosic derivative. Thecompositions are substantially clear or transparent and substantiallyanhydrous, and are effective to generate heat or warming when placed incontact with water, for example, when placed in contact with a livinghuman, such as a mucous membrane of a living human. In one usefulembodiment, the present compositions may be in the form of massagelubricants which are very effective when used on moist parts of the body(the human body) including mucus membrane tissue and/or non-mucusmembrane tissue.

The viscosities of the present compositions can be varied over arelatively broad range depending, for example, on the particularapplication for which the composition is to be used. For example, thepresent compositions can have a viscosity, at 25° C., in a range ofabout 50 cps or less to about 5000 cps or about 10,000 cps or more. Insituations where the lubricant composition is designed for use as astand alone personal lubricant or as a lubricant for a condom, forexample, a packaged lubricated condom product, viscosities (at 25° C.)of less than about 500 cps or less than about 750 cps or less than about1000 cps or less than about 2000 cps, for example, in a range of about50 cps or about 100 cps or about 300 cps to less than about 500 cps orless than about 750 cps or less than about 1000 cps or less than about2000 cps are advantageously useful.

In one very useful embodiment, the polyalkylene glycol component,preferably a polyethylene glycol component, comprises a firstpolyalkylene glycol component portion having a first molecular weightand a second polyalkylene glycol component portion having a secondmolecular weight which is reduced relative to the first molecularweight. In one embodiment, the second molecular weight is less thanabout 270. A composition including both the first and secondpolyalkylene glycol component portions has a somewhat reduced warming orheat generating effect relative to a substantially identical compositionwithout the second polyalkylene glycol component. However, a compositionincluding both first and second polyalkylene glycol portions, preferablyfirst and second polyethylene glycol portions, advantageously has areduced cloud point temperature and/or a reduced solidification point ortemperature relative to a substantially identical composition withoutthe second polyalkylene glycol portion. Preferably, the presentlubricant compositions are substantially clear or substantiallytransparent at temperatures in a range of about 20° C. to about 30° C.,for example, 25° C.

The weight ratio of the first polyalkylene glycol component portion tothe second polyalkylene glycol portion may vary over a relatively widerange, for example, from about 0.1 to about 10. Such ratio may be lessthan about 7 or less than about 3 or less than about 1.3 or lower.

In one very useful embodiment, the second polyalkylene glycol componentportion is present in a greater amount by weight than the firstpolyalkylene glycol component portion. For example, the secondpolyalkylene glycol component portion may be present in the compositionin an amount in a range of about 1.1 or about 1.5 or about 2 to about 4or about 5 or more times the amount of the first polyalkylene glycolcomponent portion in the composition. Using an excess of the secondpolyalkylene glycol component portion facilitates maintaining thecomposition substantially clear or transparent, for example, duringtransportation or periods of storage or at varying temperatures, such astemperatures below room or ambient temperature, e.g., temperatures belowabout 22° C.

The polyalkylene glycol component, for example, the first and secondpolyalkylene glycol component portions combined or together, may be atleast about 70% by weight or at least about 80% by weight or at leastabout 90% by weight of the composition. The present compositionspreferably have an enhanced ability to generate heat when placed incontact with water or when placed in contact with a mucous membrane of aliving human, relative to a similar or substantially identicalcomposition containing a reduced amount, for example, at least 5% byweight less, of the polyalkylene glycol component.

The polyalkylene glycol components, and component portions, may havemolecular weights varying over relatively wide ranges, for example, in arange of about 100 or about 150 to about 1000 or about 3000 or about5000 or more. In one embodiment, first polyalkylene, for example,polyethylene, glycol component portion preferably has a molecular weightin a range of about 350 to about 450. The second polyalkylene, forexample, polyethylene, glycol component portion preferably has amolecular weight in a range of about 150 to about 250.

The viscosity inducing components of the present lubricant compositionsmay be selected from any materials or combination of materials effectiveto increase the viscosity, and advantageously the lubricity, of thelubricant compositions, and which are compatible, that is, aresubstantially non-interfering, with or in the other components of thecompositions and with or in the application in which the compositionsare used. In one very useful embodiment, the viscosity inducingcomponent comprises a polyvinylpyrrolidone component. Suchpolyvinylpyrrolidone components are effective in the present lubricantcompositions to increase viscosity, and to provide enhanced lubricationwhen in contact with moisture relative to a composition, for example, asubstantially identical composition without the polyvinylpyrrolidonecomponent. Advantageously, the polyvinylpyrrolidone component comprisesa first polyvinylpyrrolidone component portion and a secondpolyvinylpyrrolidone component portion having a different molecularweight than the first portion. The polyvinylpyrrolidone component mayfurther include a third polyvinylpyrrolidone component portion having adifferent, for example, reduced or lower, molecular weight relative tothe molecular weights of both the first and second polyvinylpyrrolidonecomponent portions.

In a particularly useful embodiment, the relative amounts of the firstand second polyvinylpyrrolidone component portions, and the thirdpolyvinylpyrrolidone component portion, if present, are selected toprovide the desired viscosity and to be effective in controlling atleast one, and preferably both, of the tackiness of the lubricantcomposition and the stringiness of the lubricant composition. Forexample, a composition including a high molecular weightpolyvinylpyrrolidone component and no lower molecular weightpolyvinylpyrrolidone component achieves a higher viscosity, but also mayhave an undesirable degree of tackiness and/or stringiness. Thetackiness and/or stringiness of the lubricant composition is ofsubstantial importance, for example, when the composition is employed tolubricate a condom, for example, during the making of a lubricatedcondom product.

Compositions in accordance with the present invention which include apolyvinylpyrrolidone component portion having an average molecularweight which is different and reduced or lower, for example, in a rangeof about 5000 to about 15,000, relative to the molecular weight orweights of the other polyvinylpyrrolidone portion or portions presenthave increased viscosity relative to the composition without the lowermolecular weight portion and advantageously do not have the increasedstringiness of a substantially similar or identical composition havingthe same increased viscosity as the composition (which includes thelower molecular weight polyvinylpyrrolidone component portion) withoutthe lower molecular weight polyvinylpyrrolidone component portion. Inother words, a lubricant composition in accordance with the presentinvention including one or more higher molecular weightpolyvinylpyrrolidone component portions and a lower molecular weightpolyvinylpyrrolidone component portion has increased viscosity becauseof the presence of the lower molecular weight portion, but does not havethe increased stringiness apparent in a similar composition including nolower molecular weight polyvinylpyrrolidone component portion and havingits viscosity increased by an increased amount of the one or more highermolecular weight polyvinylpyrrolidone component portions.

Lubricant compositions including such reduced or lower molecular weightpolyvinylpyrrolidone component portions have been found to adhere betterto condoms and/or provide better or enhance feel or texture to users ofcondoms lubricated with the compositions or to users of the compositionsas stand alone products relative to substantially identical compositionshaving the same viscosities without the reduced molecular weightpolyvinylpyrrolidone component portions.

In another broad aspect of the present invention packaged condomproducts are provided. Such products comprise: a condom, for example,comprising latex, one or more other naturally occurring materials, suchas animal intestine material and the like, one or more other syntheticmaterials, such as synthetic polymeric materials and the like, andmixtures thereof; a lubricant composition, as described elsewhereherein; and a package containing the condom and the lubricantcomposition. The package, containing the condom and the lubricantcomposition, is sealed for transportation and storage prior to use. Inone embodiment, the condom includes an inner wall and an opposing outerwall both of which are in contact with the lubricant composition. Thepackage may be made of any suitable material or combination ofmaterials. In one embodiment, the package comprises at least one ofmetal foil and polymeric packaging material.

In a further broad aspect of the invention, methods of making ormanufacturing condom products are provided. Such methods comprise:providing a condom; contacting the condom with a lubricant composition,as described elsewhere herein, in an amount effective to lubricate thecondom for use; placing the lubricated condom in a package; and,thereafter, sealing the package, thereby forming a sealed package inwhich the condom and lubricant composition are substantially anhydrous.

Each and every feature described herein, and each and every combinationof two or more of such features, is included within the scope of thepresent invention provided that the features included in such acombination are not mutually inconsistent.

These and other aspects and advantages of the present invention willbecome apparent when considered in light of the following detaileddescription, claims and drawing in which like parts bear like referencenumerals.

BRIEF DESCRIPTION OF THE DRAWING

FIG. 1 is a front view, partly in cross-section of a sealed packagecontaining a lubricated condom in accordance with the present invention.

DETAILED DESCRIPTION

The lubricant compositions of the present invention are substantiallyanhydrous, preferably containing less than about 10% by weight of water,more preferably less than about 5% by weight of water and still morepreferably containing less than about 3% by weight of water. In one veryuseful embodiment, the present compositions are substantially free ofwater. In general, all other things being equal, the smaller the amountof water present in the composition the greater the heat generatingability of the composition.

The present lubricant compositions comprise a polyalkylene glycolcomponent and a viscosity inducing component. The polyalkylene glycolcomponents may include polyalkylene glycols, polyalkylene glycol ethers,for example, polyalkylene glycol stearates, oleates, cocoates, and thelike and mixtures thereof. Although, any suitable polyalkylene glycolcomponent may be employed, advantageously, the polyalkylene glycolcomponent is selected from polyethylene glycols (hereinafter referred toas PEG's), polyethylene glycol ethers, and the like and mixturesthereof. PEGylated compounds, such as peptide or protein derivativesobtained by PEGylation reactions may also be used. In addition, blockcopolymers of PEG's may be used, such as(ethyleneglycol)-block-poly(propyleneglycol)-block(polyethylene glycol),poly(ethylene glycol-propylene glycol) (ramdon copolymer) and the likeand mixtures thereof. The compositions of this invention comprise atleast about 50% by weight of the polyalkylene glycol component, morepreferably at least about 70%, about 80% or about 90% by weight of thecomposition.

In one very useful embodiment, the polyalkylene glycol component ispresent in different portions having different molecular weights. Forexample, in one embodiment the lubricant compositions of the presentinvention comprise a first polyalkylene glycol component portion havinga first molecular weight and a second polyalkylene glycol componentportion having a second molecular weight reduced relative to the firstmolecular weight. It has been found that controlling the molecularweight of the polyalkylene glycol component and maintaining a relativelyhigh concentration of the polyalkylene glycol component are effective inproviding the present lubricant compositions with a substantiallyadvantageous combination of benefits. For example, the presentcompositions provide an increased or enhanced degree of warming, forexample, relative to similar compositions which have less than about 50%by weight or less than about 30% by weight of the polyalkylene glycolcomponent. In addition, the lubricant compositions are substantiallyclear, and a relatively wide range of desired viscosities can be easilyobtained without substantial interference with other importantproperties, for example, tackiness and stringiness, of the presentlubricant compositions. In short, in certain embodiments of the presentinvention it is highly advantageous to have two polyalkylene glycolcomponent portions of differing molecular weights, the relativeproportions of which are advantageously controlled to providesubstantial benefits to the present compositions.

Polyalkylene glycol components, for example polyethylene glycolcomponents, and component portions, may have molecular weights varyingover relatively wide ranges, for example in a range of about 100 orabout 150 to about 1000 to about 3000 or about 5000 or more. In one veryuseful embodiment, the first polyalkylene, for example, polyethyleneglycol component portion preferably has a molecular weight in the rangeof about 350 to about 450. The second polyalkylene, for example,polyethylene glycol component portion preferably has a molecular weightof less than about 270, and more preferably in a range of about 150 toabout 250. When two polyalkylene glycol component portions are usedtogether the molecular weight difference between the two portions ispreferably at least about 100 or about 150 to about 300 or about 500 orabout 1000 or more.

In one very useful embodiment, the first polyethylene glycol componentpreferably has a molecular weight of about 350 to about 450, and isidentified as PEG 400; and the second polyethylene glycol componentportion has a molecular weight in a range of about 150 to about 250, andis preferably identified as PEG 200.

One important advantage of the present compositions is that thelubricant compositions of the present invention have a reduced cloudpoint temperature relative to a similar or substantially similarcomposition without the second polyalkylene glycol component portion.For example, by including a second polyalkylene glycol component portioncomprising PEG 200, a composition which also includes PEG 400 has areduced cloud point temperature relative to a similar composition whichincludes no PEG 200, for example, which includes an amount of PEG 400equal to the total amount of PEG 400 and PEG 200 present in thecomposition. Providing a lubricant composition with a reduced cloudpoint temperature advantageously enhances the ability of the compositionto remain clear or substantially clear over a broader range oftemperatures.

The weight ratio of the first polyalkylene glycol component portion tothe second polyalkylene glycol portion may vary over a relatively widerange, for example, from about 0.1 to about 10. Such ratio may be lessthan about 7 or less than about 3 or less than about 1.3 or lower, forexample, less than about 1.0 or less than about 0.5 or lower.

In one very useful embodiment, the lower molecular weight secondpolyalkylene glycol component portion is present in a greater amount byweight than the higher molecular weight first polyalkylene glycolcomponent portion. For example, the second polyalkylene glycol componentportion such as a polyethylene glycol component portion having arelatively low molecular weight, may be present in the composition in anamount in a range of about 1.1 or about 1.5 or about 2 to about 4 orabout 5 or more times the amount of the first polyalkylene glycolcomponent portion, such as a polyethylene glycol component portionhaving a relatively high molecular weight, in the composition. Using anexcess of the second polyalkylene glycol component portion facilitatesmaintaining the composition substantially clear or transparent, forexample, during transportation or periods of storage or at varyingtemperatures, such as temperatures below room or ambient temperature,e.g., temperatures below about 22° C.

The present compositions include an effective amount of a viscosityinducing component. As noted elsewhere herein, the viscosity inducingcomponent may be selected from any material or combination of materialseffective to increase, preferably controllably increase, the viscosityof the composition. The presently useful viscosity inducing componentsadvantageously are compatible, that is are substantially non-interferingwith or in the other components of the composition and with or in theapplication in which the composition is used. In one embodiment, theviscosity inducing component is other than a cellulosic derivative,although in other of the present lubricant compositions cellulosicderivatives may be employed. In one embodiment, the present compositionsare substantially free of any cellulosic derivatives.

In a very useful embodiment of the present invention, the viscosityinducing component comprises a polyvinylpyrrolidone component. Suchpolyvinylpyyrolidone (PVP) component is very effective in providingcontrolled increases in viscosity at relatively low concentrationswhile, at the same time, providing increases in lubricity to the presentcompositions.

Advantageously, the PVP component comprises a first PVP componentportion and a second PVP component portion having a different molecularweight than the first portion. The PVP component may include a third PVPcomponent portion having a different, and preferably reduced, molecularweight then both the first and second PVP component portions. Therelative amounts of the first and second, and third if present, PVPcomponent portions may be selected to be effective in controlling atleast one, and preferably both, of the tackiness of the composition andthe stringiness of the composition. The tackiness and/or stringiness ofthe present compositions are of substantial importance, for example,when the composition is employed to lubricate a condom, for exampleduring the making of such a lubricated condom product. In addition, evenas a stand-alone lubricant product, for example, for use as a personallubricant, the present lubricant compositions advantageously havecontrolled tackiness and/or controlled stringiness to be an estheticallypleasing product, for example, being substantially uniform and/or smoothand/or having a substantially consistent texture, when applied to thehuman body. Preferably, the compositions of the present inventioncontain about 1% to about 15%, more preferably about 2% to about 10% byweight of the viscosity inducing component, for example the PVPcomponent.

In the event that a first viscosity inducing component portion and asecond viscosity inducing component portion having a reduced molecularweight relative to the first portion are employed in the presentlubricant compositions, the relative amounts of the first and secondportions may vary over a relatively wide range, for example, tofacilitate providing a composition having the desired properties for anyone of a number of relatively widely varying applications. For example,the weight ratio of first portion to second portion may range from about0.05 or about 0.1 to about 0.3 or about 0.5 or about 1 or higher. In theevent first and second PVP portions are employed, the weight ratio offirst portion to second portion is advantageously in the range of about0.1 to about 0.3.

The molecular weight of the viscosity inducing component may be in arange of about 5000 or about 10,000 to about 100,000 or about 1,500,000or higher.

In one embodiment, the present compositions include a first PVPcomponent portion having a molecular weight in a range of about 100,000to about 1,500,000 or higher, for example, about 300,000 to about1,000,000; and a second PVP component portion having an averagemolecular weight in a range of about 25,000 to about 90,000, forexample, about 35,000 to about 55,000. A reduced or lower molecularweight, for example, a third, PVP component portion may be present, asdiscussed elsewhere herein, and advantageously have an average molecularweight of about 3000 to about 20,000, for example, about 5,000 to about15,000.

The present lubricant compositions increase in temperature upon exposureto moisture from the skin or mucosa, without causing undue irritation orharm to the skin or mucosal surfaces.

This warming occurs by the exothermic release of energy generated uponexposing the compositions to water. The temperature increaseadvantageously falls within a comfort range from the minimum perceptibletemperature increase to no more than that perceived as too hot, forexample, causing irritation or other harm to the skin or mucosa.

Without wishing to limit the invention to any particular theory ofoperation, it is believed that the polyalkylene glycol components in thepresent compositions are useful as warming or heat-generating agents.The viscosity inducing component is useful to increase, preferablycontrollably increase the viscosity of the lubricant. The presentcompositions are advantageous in that they lubricate, warm, and soothethe tissues of the user, especially the oral and vaginal mucousmembranes. Moreover, they are advantageously smooth and lubricating,rather than being stringy and tacky.

The present compositions may be in the form of a liquid, a semi-solid,or a solid depending upon the particular intended use thereof. Thepresent compositions may be formulated as syrupy liquid-gels pourablegels or thick jellies or as pourable liquids. Preferably, theviscosities are in a range of about 50 cps or about 100 cps to less thanabout 500 cps or less than about 1000 cps or less than about 2000 cps.However, as noted above, viscosities in the present compositions mayrange from about 1000 cps to about 10,000 cps for gel, and from 60,000cps to about 500,000 cps or more for the jellies. The presentcompositions may also be formulated into soft or hard gelatin capsules,suppositories and impregnated into fabrics or polymers.

A preservative component may be added to guard against microbial growth.The preservative component may be selected from preservatives known tothose of skill in the art, including, but not limited to, one or more ofthe following: methylparaben, benzoic acid, sorbic acid, gallic acid,propylparaben and the like and mixtures thereof. The preservativecomponent may be present, if at all, in the present compositions in anamount in a range of about 0.01% or less to about 0.5% or more byweight.

The compositions of this invention may be used as personal lubricantswhich convey a feeling of warmth. The feeling of warmth generated by thecompositions of this invention is soothing to the skin or mucousmembranes where they are applied. The compositions of the invention mayalso possess a sweet and pleasant taste, and may optionally includeeffective amounts of sweetening agents and/or flavoring agents which areof particular benefit when these compositions are used orally.

The compositions of this invention may also be used as personalmoisturizers, which convey a feeling of warmth when applied to vaginalor oral mucosa. Such warming effect has been found to enhance intimacyand increase pleasure during intimate activities. Flavors and fragrancesthat enhance different senses and promote relaxation or intimacy mayalso be added to the compositions of this invention to enhance theireffect, both in improving intimacy and in creating a feeling ofrelaxation.

The present compositions may be used to relieve vaginal dryness or drymouth, to moisturize skin, to provide an ameliorating effect forfrostbite or extremities overexposed to the cold and the likeapplications. The present compositions may be useful for treatingconditions of infection on the skin or mucosa while soothing the area ofinfection.

The present compositions may also be used as vehicles to delivermedication or other treatment agents to biomembranes including, but notlimited to, hormones, antimicrobials, antibacterials, antibiotics,non-steroidal anti-inflammatory agents, spermicides, immunodilators,anaesthetics, plant extracts, vitamins, corticosteroids or antifungalagents and the like and mixtures thereof.

Antifungal agents are preferably azoles or imidazoles, including by notlimited to, miconazole, econazole, terconazole, saperconazole,itraconazole, butaconazole, clotrimazole, tioconazole, fluconazole andketocanazole, vericonazole, fenticonazole, sertaconazole, posaconazole,bifonazole, oxiconazole, sulconazole, elubio, vorconazole, isoconazole,flutimazole, tioconazole and their pharmaceutically acceptable salts andthe like. Other antifungal agents may include an allylamine or one fromother chemical families, including but not limited to, ternafine,naftifine, amorolfine, butenafine, ciclopirox, griseofulvin,undecyclenic acid, haloprogin, tolnaftate, nystatin, iodine, rilopirox,BAY 108888, purpuromycin and their pharmaceutically acceptable salts.

The present compositions, for example, for vulvovaginal or other mucosaluse, may include one or more antibiotics including, but not limited to,metronidazole, clindamycin, tinidazole, ornidazole, secnidazole,refaximin, trospectomycin, purpuromycin and their pharmaceuticallyacceptable salts and the like and mixtures thereof.

The present compositions, for example, for vulvovaginal or other mucosaluse, may include one or more antiviral agents including but are notlimited to, immunomodulators, more preferably imiquimod, derivativesthereof, podofilox, podophyllin, interferon alpha, reticolos, cidofovir,nonoxynol-9, pharmaceutically acceptable salts thereof and the like andmixtures thereof.

The present compositions may include one or more spermicides including,but are not limited to, nonoxynol-9, octoxynol-9, dodecaethyleneglycolmonolaurate, Laureth 10S, and Methoxypolyoxyethyleneglycol 550 Laurateand the like and mixtures thereof.

The present compositions may include antimicrobial agents, including butare not limited to, chlorohexidine gluconate, sodium polystyrenesulfonate, sodium cellulose sulfate, silver particles of micro- andsub-micrometer sizes, silver salts and other antibacterial agents knownto the art and the like and mixtures thereof.

The present compositions may include local anesthetics, including butare not limited to, benzocaine, lidocaine, dibucaine, benzyl alcohol,camphor, resorcinol, menthol and diphenylhydramine hydrochloride and thelike and mixtures thereof.

The present compositions may include plant extracts such as aloe, witchhazel, chamomile, hydrogentated soy oil and colloidal oatmeal, vitaminssuch as vitamin A, D or E and corticosteroids such as hydrocortisoneacetate, and the like and mixtures thereof.

The present compositions, for example, for vulvovaginal or other mucosaluse, may include one or more hormones for treating a decrease inestrogen secretion in the woman in need of estrogen replacement, such aswomen with vaginal atrophy. The hormones may include, but are notlimited to, estrogen elected from the group consisting of estradiol,estradiol benzoate, estradiol cypionate, estradiol dipropinonate,estradiol enanthate, conjugated estrogen, estriol, estrone, estronesulfate, ethinyl estradiol, estrofurate, quinestrol and mestranol andthe like and mixtures thereof.

The present compositions may be useful for treating female sexualdysfunction by themselves as such compositions may serve to increaseblood flow to areas on which such compositions are applied by increasingtemperature thereon. Alternatively, the compositions may contain agentsknown to those of skill in the art to treat female sexual dysfunction(including different aspects of female sexual dysfunction such as femalesexual arousal disorder, hypoactive sexual desire disorder, orgasmicdisorder and the like) as well as those that treat dyspareunia and/orvaginismus or vulvodynia and to relieve pain upon intercourse. Suchagents include hormones such as estrogen, prostaglandin, testosterone;calcium channel blockers, cholinergic modulators, alpha-adrenergicreceptor antagonist, beta-adrenergic receptor agonists, camp-dependentprotein kinase activators, superoxide scavengers, potassium channelactivators, estrogen-like compounds, testosterone-like compounds,benzodiazepines, adrenergic nerve inhibitors, HMG-COA reductaseinhibitors, smooth muscle relaxants, adrenosine receptor modulators andadenylyl cyclase activators. Such agents include phosphodiesterase-5inhibitors and the like. The present compositions may also containvasodilators such as methyl nicotinate, histamine hydrochloride and verysmall non-irritating amounts of methyl salicylate.

The present compositions, for example, for vulvovaginal use, may containone or more analgesics and/or nonsteroidal anti-inflammatory agents fortreating dysmenorrhea or menstrual cramping. The analgesics andnonsteroidal anti-inflammatory agents may include, but are not limitedto, aspirin, ibuprofen, indomethacin, phenylbutazone, bromfenac,fenamate, sulidac, nabumetone, ketorolac, and naproxen and the like andmixtures thereof.

The present compositions, for example, for oral, vulvovaginal and/orother mucosal use, may enhance the absorption of active agents from theapplied compositions into the mucosal membrane by increasing thecomposition and mucosal tissue temperature upon contact with the tissue.

The present compositions, for example, for vulvovaginal use, may preventand/or treat dysmenorrhea by intravaginal warming or heating.Preferably, the composition heats the intravaginal area to a temperaturepreferably between about 37° C. and about 42° C., more preferablybetween about 38° C. and about 41° C. The compositions of the inventionfor use in such a method may optionally contain active agents such asanalgesics and nonsteroidal anti-inflammatory agents for dysmenorrheatreatment. The composition of the invention may be administered directlyinto the vagina by an applicator, or be impregnated into vaginal devicessuch as tampon for intravaginal applications.

The present compositions may be manufactured as a coating of a tampon,or dispersing throughout the absorbent tampon material, or enclosedinside as a core of a tampon.

The present compositions may be applied to the oral or vaginal mucosaltissues manually or via a swab or vaginal applicator of in any way knownto those of ordinary skill in the art.

In one particularly useful aspect of the present invention, the presentlubricant compositions may be employed in the manufacture of a packagedcondom product.

Such a method of manufacturing a condom product is included within thescope of the present invention and comprises providing a condom, forexample a condom which comprises latex. The condom is contacted with alubricant composition, for example in accordance with the presentinvention as described elsewhere herein, in an amount effective tolubricate the condom for use. Advantageously, both the inner wall of thecondom and the outer wall of the condom are contacted and lubricatedwith the lubricant composition. The lubricated condom is placed in apackage which is thereafter sealed to form a sealed package in which thecondom and lubricant composition are substantially anhydrous.

The package is opened to remove the condom, which is then available foruse, as desired.

A packaged condom product is also an aspect of the present invention andis included within the scope of the present invention. Such a packagedcondom product is shown in FIG. 1.

Referring now to FIG. 1, the packaged condom product shown generally at10 includes a sealed package 12, and a rolled condom 14. The package 12is made of conventional polymeric packaging material and/or conventionalmetal foil packaging material.

The inner and outer walls of the condom 14, which is made of latex, arelubricated with a substantially clear lubricant composition inaccordance with the present invention. Such lubricant, shown as 16 isadvantageously substantially not stringy and has a control degree oftackiness, from the use of a PVP component or component portions, asdescribed elsewhere herein in the lubricant composition.

The sealed package 12 includes front wall 15, back wall 17 and seals 18and 20, which together form an outer perimeter region of the package.Either or both of the seals 18, 20 can be compromised to remove thecondom from the package 12, for use, as desired.

The packaged condom product 10 is made using conventional condommanufacturing equipment in which the lubricant composition 16 isincluded with the condom during the normal course of manufacture, forexample, in a manner substantially similar to that used to lubricatecondoms with conventional condom lubricants.

One important advantage of the present invention is that the stringinessand/or tackiness of the lubricant compositions are controlled tofacilitate the lubrication of and overall manufacturing efficiency ofthe final packaged condom product in a cost effective way, for examplemeeting satisfactory production rates while still providing the addedadvantage of providing a warming lubricant composition onto the condom.Thus, such warming is provided without substantial disruption to thecondom manufacturing operation, for example, such an operation that isconventionally employed with conventional condom lubricants that arenon-warming. This is an important advantage and provides substantialbenefits, for example, increased user enjoyment, without substantiallyadding to the manufacturing cost of the packaged condom product.

The following non-limiting examples illustrate certain aspects of thepresent invention.

EXAMPLES 1 to 8

A series of eight (8) compositions were prepared for testing. Thesecompositions were anhydrous and had chemical make-ups as shown inTable 1. The compositions were formed by combining or blending theingredients together and stirring or mixing to obtain a uniformcomposition. The compositions of the present invention preferably aremade from NF grade materials, which reduce the toxicity of thecompositions.

Each of these compositions was tested in condom lubrication service.Briefly, commercial condom processing equipment was used during thetesting. Each of the compositions was used during a trial run in whichcondoms were doubly lubricated, that is both the inner wall and theouter wall of the condom were lubricated, and the lubricated condomswere placed in individual packages which were then sealed.

TABLE 1 COMPOSITIONS INGREDIENT % by wt 1 2 3 4 5 6 7 8 % % % % % % % %by wt by wt by wt by wt by wt by wt by wt by wt PEG 400 (A) 91.0 93.089.0 65.4 83.35 50.0 26.55 24.0 PEG 200 (B) — — — 25.0 12.50 45.5 70.870.25 BUTYLENE — — — — — — — — GLYCOL LUVISKOL 9.0 7.0 1.0 0.8 — — — —K90 (C) LUVISKOL — — 10.0 8.8 — — — — K30 (D) KOLLIDON — — — — — — 0.250.5 K17 (E) KOLLIDON — — — — 3.75 3.75 2.0 4.0 30 (F) KOLLIDON — — — —0.40 0.75 0.4 1.25 90F (G) VISCOSITY 10,800 5400 3250 1400 350 450550-650 500-650 cps @25° C. (A) Polyethylene glycol having a molecularweight of about 400 (Sold by BASF) (Equivalent products produced by DowChemical). (B) Polyethlyene glycol having a molecular weight of about200 (Sold by BASF) (Equivalent products produced by Dow Chemical). (C)Polyvinylpyrrolidone having an average molecular weight of about300,000-1,000,000 or about 360,000 (Sold by BASF) (Equivalent productsproduced by ISP). (D) Polyvinylpyrrolidone having an average molecularweight of about 35,000-55,000 or about 40,000 (Sold by BASF) (Equivalentproducts produced by ISP). (E) Polyvinylpyrrolidone having an averagemolecular weight of about 5,000-15,000 or about 10,000 (Sold by BASF)(Equivalent products produced by ISP). (F) Polyvinylpyrrolidone havingan average molecular weight of about 35,000-55,000 or about 40,000 (Soldby BASF) (Equivalent products produced by ISP). (G) Polyvinylpyrrolidonehaving an average molecular weight of about 300,000-1,000,000 or about360,000 (Sold by BASF) (Equivalent products produced by ISP).

A summary of the test results obtained with each of the compositions isas follows:

-   Composition 1: lubricant was completely clear and had a relatively    dark yellow color; lubricant was too tacky and viscosity too high to    maintain satisfactory condom production rate.-   Composition 2: lubricant was completely clear and had a relatively    dark yellow color; lubricant was too tacky and viscosity was still    too high.-   Composition 3: lubricant was completely clear and had a yellow color    somewhat lighter than the color of Compositions 1 and 2; lubricant    was still too viscous to maintain satisfactory condom production    rate.-   Composition 4: lubricant was completely clear and had a yellow color    somewhat lighter than the color of Compositions 1 and 2; lubricant    was still too viscous to maintain satisfactory condom production    rate.-   Composition 5: lubricant was completely clear and had a    substantially water white color; lubricant had reduced viscosity,    stringiness and tackiness relative to Composition 4; production    equipment was marginally able to maintain satisfactory condom    production rate using Composition 5.-   Composition 6: lubricant was completely clear and had a    substantially water white color; lubricant had reduced viscosity,    stringiness and tackiness relative to Composition 4; production    equipment was able to maintain satisfactory condom production rate    using Composition 6.-   Composition 7: lubricant was completely clear and had a    substantially water white color; lubricant had reduced viscosity,    stringiness and tackiness relative to Composition 4, and increased    viscosity without increased stringiness relative to Composition 6;    production equipment was able to maintain satisfactory condom    production rate using Composition 7.-   Composition 8: lubricant was completely clear and had a    substantially water white color; lubricant had reduced viscosity,    stringiness and tackiness relative to Composition 4, and increased    viscosity without increased stringiness relative to Composition 6;    production equipment was able to maintain satisfactory condom    production rate using Composition 8.

These data indicate that the inclusion of relatively large amounts ofpolyvinylpyrrolidone component in the present lubricants results in thelubricants becoming yellow in color, with the higher molecular weightpolyvinylpyrrolidone material providing a darker yellow color. Thelubricants used on condoms and in condom manufacturing can have a degreeof color and still be acceptable. Also, lubricants in accordance withthe present inventions provided as separate or stand alone products mayhave a color other than water white and be acceptable. However, it ispreferred, for example, in stand alone or separate lubricants, that suchlubricants have a substantially water white color.

Composition 7 and 8 include a lower molecular weightpolyvinylpyrrolidone. It has been found that such lower molecular weightpolyvinylpyrrolidone, for example in combination with one or more, suchas two, different higher molecular weight polyvinylpyrrolidones, as inCompositions 7 and 8, is useful to increase the viscosity of thelubricant without disadvantageously increasing the stringiness of thelubricant. Controlling or increasing the viscosity of the lubricant, forexample, by including a lower molecular weight polyvinylpyrrolidone asshown in Composition 7 and 8, advantageously provides a lubricant whichadheres better to the condom and/or provides a better feel or texture tothe users of the condoms relative to a substantially identical lubricanthaving the same viscosity without the lower molecular weightpolyvinylpyrrolidone.

EXAMPLES 9 TO 16

Each of the Compositions 1 to 8 is tested for heat generation efficacyrelative to a commercially available product, in particular KY WarmingLubricant. Briefly, 50 grams of each of the Compositions 1 to 7 and KYWarming Lubricant is placed in a container holding 50 grams of water.Each mixture is stirred. The temperature of each mixture is monitoreduntil the temperature reaches a steady value. That temperature is noted.

The temperature noted in this test with each of the Compositions 1 to 8is higher than the temperature in the test with KY Warming Lubricant.

These results indicate that each of the Compositions 1 to 8 provideenhanced heat generation relative to KY Warming Lubricant.

It should be noted that the maximum temperature increase obtained by anywarming lubricant varies depending on how much lubricant is used and theindividual application in which the lubricant is used, among otherfactors. The tests and results presented here do, however, demonstratethat the Compositions 1 to 8 provide increased heat generation, on a perunit weight basis, relative to KY Warming Lubricant.

EXAMPLES 17 TO 20

Compositions 5, 6, 7 and 8 are each augmented with 2.0% by weight ofmiconazole nitrate. The resulting Compositions 9, 10, 11 and 12,respectively, are found in in vitro testing to be effective in killinganaenobes known to cause bacterial vaginal infections, and Candidaalbicans, known to cause vulvovaginal candidiasis. Thus, such augmentedcompositions can be used to treat or be a prophylactic against suchinfections by applying the composition to the affected area or area inquestion of the body.

While this invention has been described with respect to various specificexamples and embodiments, it is to be understood that the invention isnot limited thereto and that it can be variously practiced within thescope of the following claims.

What is claimed is:
 1. A lubricant composition comprising: a firstpolyethylene glycol component portion having a first molecular weightrange; and a second polyethylene glycol component portion having asecond molecular weight range reduced relative to the first molecularweight range; and an effective amount of a viscosity inducing componentcomprising a first polyvinylpyrrolidone component portion and a secondpolyvinylpyrrolidone component portion having a different averagemolecular weight than the first polyvinylpyrrolidone portion, whereinthe first and second polyvinylpyrrolidone component portions togetherare present in a combined concentration of from about 1% to about 15% byweight, the first and second polyethylene glycol component portionstogether comprise at least about 50% by weight of the composition andthe second polyethylene glycol component portion is present in a greateramount by weight than the first polyethylene glycol component portion,the composition being substantially clear, uniform, smooth andsubstantially anhydrous, and being effective to generate heat whenplaced in contact with water, wherein the weight ratio of the secondpolyethylene glycol component portion to the first polyethylene glycolcomponent portion is from 1.1 to about 6.7, and wherein said lubricantcomposition is substantially non-toxic and suitable for application as apersonal lubricant to human skin or mucosal surfaces without causingundue irritation or harm, to increase pleasure during intimateactivities.
 2. The composition of claim 1 having a viscosity in a rangeof about 50 cps to less than 10,000 cps at 25° C.
 3. The composition ofclaim 1 wherein the first polyethylene glycol component portion has amolecular weight range of about 350 to about 450 and the secondpolyethylene glycol component portion has a molecular weight range ofabout 150 to about
 250. 4. The composition of claim 1 wherein thepolyvinylpyrrolidone component includes a third polyvinylpyrrolidonecomponent portion having a different average molecular weight than boththe first and second portions.
 5. The composition of claim 4 wherein therelative amounts of the first, second and third polyvinylpyrrolidonecomponent portions are selected to be effective in controlling at leastone of the tackiness of the composition and the stringiness of thecomposition, as desired.
 6. A lubricant composition comprising: a firstpolyalkylene glycol component portion having a first molecular weightrange; and a second polyalkylene glycol component portion having asecond molecular weight range reduced relative to the first molecularweight range and the second polyalkylene glycol component portion ispresent in a greater amount by weight than the first polyalkylene glycolcomponent portion, wherein the weight ratio of the second polyalkyleneglycol component portion to the first polyalkylene glycol componentportion is from about 1.1 to about 6.7; and an effective viscosityinducing amount of a polyvinylpyrrolidone component comprising a firstpolyvinylpyrrolidone component portion and a second polyvinylpyrrolidonecomponent portion having a different average molecular weight than thefirst polyvinylpyrrolidone portion wherein, the first and secondpolyvinylpyrrolidone component portions together are present in acombined concentration of from about 1% to about 15% by weight, thefirst and second polyalkylene glycol components portions of differentmolecular weight ranges are comprised of the same polyalkylene glycol,the first and second polyalkylene component portions together comprisingat least about 50% by weight of the composition, the composition beingsubstantially clear, uniform, smooth and substantially anhydrous, andbeing effective to generate heat when placed in contact with water, andwherein said lubricant composition is substantially non-toxic andsuitable for application as a personal lubricant to human skin ormucosal surfaces without causing undue irritation or harm, to increasepleasure during intimate activities.
 7. The composition of claim 6wherein the first and second polyalkylene glycol component portions arepolyethylene glycol component portions.
 8. The lubricant composition ofclaim 6 comprising a third polyvinylpyrrolidone component portion havinga different and lower average molecular weight than both the first andsecond portions.
 9. The composition of claim 8 wherein the polyalkyleneglycol component comprises a polyethylene glycol component.